A Study to Investigate the Safety and Effectiveness of Remimazolam Sedation During Bronchoscopy

Efficacy and Safety of Remimazolam for Bronchoscopy: A Single-Arm Prospective Pilot Study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs051250268

Enrollment

Registered

2026-04-01

Start date

2026-04-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conditions requiring bronchoscopy with biopsy bronchoscopy

Interventions

Remimazolam will be administered intravenously for sedation during bronchoscopy. The dosage will be based on the package insert for gastrointestinal endoscopy, with half doses for patients aged 75 yea

D001569

remimazolam

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients aged 18 years or older at the time of obtaining informed consent 2.Patients scheduled to undergo bronchoscopy with biopsy 3.Able to provide written informed consent voluntarily for participation in this clinical study

Exclusion criteria

Exclusion criteria: 1.History of hypersensitivity to any component of the study drug 2.Acute angle-closure glaucoma 3.Myasthenia gravis 4.Unable to discontinue benzodiazepine medications at least 4 days prior to bronchoscopy 5.Currently taking opioids 6.Severe organ dysfunction including severe hepatic impairment 7.Currently receiving oxygen therapy or resting room air SpO2 less than 94% 8.Uncontrolled hypertension 9.Clinically significant hypotension 10.Pregnant or potentially pregnant women, and breastfeeding women 11.Any other condition judged inappropriate for participation in this clinical study by the investigator

Design outcomes

Primary

Measure	Time frame
Completion of the planned bronchoscopy examination	—

Secondary

Measure	Time frame
Efficacy Endpoints VAS score representing the degree of distress, including physical pain and psychological distress, experienced by study subjects during bronchoscopy VAS score representing the degree of satisfaction of the principal investigator or sub investigator who performed the bronchoscopy Dose of remimazolam and number of additional administrations Dose of fentanyl when fentanyl is used BIS value and MOAAS scale during the procedure Success of diagnosis Procedure time, presence or absence of procedure interruption, duration of procedure interruption, time to awakening The number of biopsies Safety Endpoints SpO2, oxygen requirement, respiratory rate, blood pressure, heart rate, and adverse events during the procedure Use or non use of flumazenil or naloxone Adverse events during the observation period following remimazolam administration	—

Measure

Time frame

Efficacy Endpoints VAS score representing the degree of distress, including physical pain and psychological distress, experienced by study subjects during bronchoscopy VAS score representing the degree of satisfaction of the principal investigator or sub investigator who performed the bronchoscopy Dose of remimazolam and number of additional administrations Dose of fentanyl when fentanyl is used BIS value and MOAAS scale during the procedure Success of diagnosis Procedure time, presence or absence of procedure interruption, duration of procedure interruption, time to awakening The number of biopsies Safety Endpoints SpO2, oxygen requirement, respiratory rate, blood pressure, heart rate, and adverse events during the procedure Use or non use of flumazenil or naloxone Adverse events during the observation period following remimazolam administration

—

Contacts

Public ContactNaoko Katsurada

Kobe University Hospital

yniwasa1208@hotmail.com+81-78-382-5660

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026